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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00062127

Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors

A Phase 1 study testing irinotecan hydrochloride, thalidomide and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
irinotecan hydrochloride, thalidomide and pharmacological study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Apr 2003to May 2006
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed malignant solid tumor
  • Metastatic or unresectable
  • Standard curative or palliative therapy is no longer effective or does not exist
  • Measurable or assessable disease
  • No uncontrolled brain metastases
  • Patients with brain metastases are eligible provided the following are true:
Show all 45Show fewer
  • Stable neurologic status
  • At least 4 weeks since prior steroids or anticonvulsants
  • No neurologic dysfunction that would confound evaluation
  • Performance status - Karnofsky 70-100%
  • More than 12 weeks
  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin normal
  • AST and ALT no greater than 2.5 times upper limit of normal
  • Creatinine normal
  • Creatinine clearance at least 60 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No history of inflammatory bowel disease requiring therapy
  • No chronic diarrhea syndromes
  • No paralytic ileus
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile female patients must use 2 forms of effective contraception, including 1 highly effective method, for at least 4 weeks before, during, and for 4 weeks after study participation
  • Male patients must use effective barrier contraception during and for 4 weeks after study participation
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
  • No uncontrolled seizure disorder
  • No other concurrent uncontrolled illness that would preclude study participation
  • No psychiatric illness or social situation that would preclude study compliance
  • No ongoing or active infection
  • No significant traumatic injury within the past 28 days
  • No serious, nonhealing wounds or ulcers
  • No bone fractures
  • No preexisting peripheral neuropathy grade 2 or greater
  • At least 4 weeks since prior biologic therapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • More than 28 days since prior major surgical procedure or open biopsy
  • At least 4 weeks since prior investigational therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or commercial agents or therapies for the malignancy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637-1470

Other trials in United States

About this study

Official title: A Phase I Pharmacokinetic Interaction Study of Irinotecan (NSC616348) and Thalidomide (NSC66847) in Patients With Advanced Solid Tumors

Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill more tumor cells. This randomized phase I trial is studying the side effects and best way to give irinotecan and thalidomide in treating patients with metastatic or unresectable solid tumors

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine whether thalidomide alters the pharmacokinetics of irinotecan in patients with advanced solid tumors.

II. Determine whether irinotecan alters the pharmacokinetics of thalidomide in these patients.

III. Determine the toxicity of this regimen in these patients. IV. Determine the observed antitumor response in patients treated with this regimen.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28.

Arm II: Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7.

All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00062127
Study groupRoleWhat they receive
Arm I (irinotecan hydrochloride and thalidomide)ExperimentalPatients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28. All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: irinotecan hydrochloride; Drug: thalidomide; Other: pharmacological study
Arm II (irinotecan hydrochloride and thalidomide)ExperimentalPatients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7. All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: irinotecan hydrochloride; Drug: thalidomide; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of thalidomide on irinotecan hydrochloride pharmacokinetics

    Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours

  2. Effect of irinotecan hydrochloride on thalidomide pharmacokinetics

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 and 168 hours

  3. Grade 3 or greater toxicities assessed using NCI CTC version 2.0

    Will be summarized and analyzed using descriptive statistics. Exact 90% confidence intervals using the binomial distribution will be derived.

    Measured: Up to 3 years

  4. Response assessed using RECIST criteria

    Will be summarized and analyzed using descriptive statistics. Exact 90% confidence intervals using the binomial distribution will be derived.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2003 (estimated)
  2. Study startApr 2003
  3. Primary completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00062127
Sponsor's protocol ID
NCI-2012-02537
Other IDs
12044B, U01CA069852, CDR0000304517
Status last verified
Jan 2013
First submitted
5 Jun 2003
Last updated
24 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing irinotecan hydrochloride, thalidomide and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 45 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of thalidomide on irinotecan hydrochloride pharmacokinetics (time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00062127.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.

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